[Federal Register Volume 73, Number 34 (Wednesday, February 20, 2008)]
[Rules and Regulations]
[Pages 9226-9232]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-2906]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0916; FRL-8343-6]


Formetanate Hydrochloride; Pesticide Tolerances for Emergency 
Exemptions

AGENCY: Environmental Protection Agency (EPA).

[[Page 9227]]


ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
residues of formetanate hydrochloride, m-
[[(dimethylamino)methylene]amino]phenyl methylcarbamate hydrochloride, 
in or on dry bulb onions. This action is in response to EPA's granting 
of emergency exemptions under section 18 of the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide 
on dry bulb onions. This regulation establishes a maximum permissible 
level for residues of formetanate hydrochloride in this food commodity. 
The tolerance expires and is revoked on December 31, 2008.

DATES: This regulation is effective February 20, 2008. Objections and 
requests for hearings must be received on or before April 21, 2008, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION.

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2006-0916. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available either in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the Office 
of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One 
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The 
hours of operation of this Docket Facility are from 8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays. The Docket 
Facility telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9367; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

 B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), 
any person may file an objection to any aspect of this regulation and 
may also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. You must file your objection or 
request a hearing on this regulation in accordance with the 
instructions provided in 40 CFR part 178. To ensure proper receipt by 
EPA, you must identify docket ID number EPA-HQ-OPP-2006-0916 in the 
subject line on the first page of your submission. All requests must be 
in writing, and must be mailed or delivered to the Hearing Clerk on or 
before April 21, 2008.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2006-0916., by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408 (l)(6) of FFDCA, 21 U.S.C. 346a, is establishing a tolerance for 
residues of the insecticide formetanate hydrochloride, m-
[[(dimethylamino)methylene]amino]phenyl methylcarbamate hydrochloride, 
in or on onions, dry bulb at 0.02 parts per million (ppm). This 
tolerance expires and is revoked on December 31, 2008. EPA will publish 
a document in the Federal Register to remove the revoked tolerance from 
the CFR.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited 
tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related tolerances

[[Page 9228]]

to set binding precedents for the application of section 408 of FFDCA 
to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA 
to establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' This provision was not 
amended by FQPA. EPA has established regulations governing such 
emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Formetanate Hydrochloride on Dry Bulb 
Onions and FFDCA Tolerances

    The states of Idaho, Oregon, Colorado, Michigan, Ohio, Wisconsin, 
Texas and New York requested the use of formetanate hydrochloride, 
formulated as the product Carzol, on dry bulb onions to control thrips. 
According to these states, the available registered alternatives were 
not providing adequate control of this pest and without the use of 
Carzol, growers would suffer significant economic losses. After having 
reviewed the submissions, EPA concurred that emergency conditions exist 
and authorized under FIFRA section 18 the use of formetanate 
hydrochloride on dry bulb onions for control of thrips in Idaho, 
Oregon, Colorado, Michigan, Ohio, Wisconsin, Texas and New York.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of formetanate hydrochloride 
in or on dry bulb onions. In doing so, EPA considered the safety 
standard in section 408(b)(2) of FFDCA, and EPA decided that the 
necessary tolerance under section 408(l)(6) of FFDCA would be 
consistent with the safety standard and with FIFRA section 18. 
Consistent with the need to move quickly on the emergency exemption in 
order to address an urgent non-routine situation and to ensure that the 
resulting food is safe and lawful, EPA is issuing this tolerance 
without notice and opportunity for public comment as provided in 
section 408(l)(6) of FFDCA. Although this tolerance expires and is 
revoked on December 31, 2008, under section 408(l)(5) of FFDCA, 
residues of the pesticide not in excess of the amounts specified in the 
tolerance remaining in or on dry bulb onions after that date will not 
be unlawful, provided the pesticide is applied in a manner that was 
lawful under FIFRA, and the residues do not exceed a level that was 
authorized by this tolerance at the time of that application. EPA will 
take action to revoke this tolerance earlier if any experience with, 
scientific data on, or other relevant information on this pesticide 
indicate that the residues are not safe.
    Because this tolerance is being approved under emergency 
conditions, EPA has not made any decisions about whether formetanate 
hydrochloride meets EPA's registration requirements for use on dry bulb 
onions or whether a permanent tolerance for this use would be 
appropriate. Under these circumstances, EPA does not believe that this 
tolerance serves as a basis for registration of formetanate 
hydrochloride by a State for special local needs under FIFRA section 
24(c). Nor does this tolerance serve as the basis for persons in any 
State other than Idaho, Oregon, Colorado, Michigan, Ohio, Wisconsin, 
Texas and New York to use this pesticide on this crop under section 18 
of FIFRA. For additional information regarding the emergency exemption 
for formetanate hydrochloride, contact the Agency's Registration 
Division at the address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of FFDCA and a complete 
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of 
formetanate hydrochloride and to make a determination on aggregate 
exposure, consistent with section 408(b)(2) of FFDCA, for a time-
limited tolerance for residues of formetanate hydrochloride in or on 
onions, dry bulb at 0.02 ppm. EPA's assessment of the dietary exposures 
and risks associated with establishing the tolerance follows. In 
addition, an Interim Reregistration Eligibility Decision (IRED) 
Document was published in March 2006. This IRED was proposed to become 
a final RED in the N-methyl Carbamate Revised Cumulative Risk 
Assessment that was made available for public comment on September 26, 
2007. This IRED/RED provides additional information and more detail on 
the dietary exposures and risks associated with formetanate 
hydrochloride. The link for this document on the EPA website is: http://www.epa.gov/oppsrrd1/REDs/formetanatehcl_ired.pdf.

A. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological endpoint. However, the 
lowest dose at which adverse effects of concern are identified (the 
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved 
in the toxicology study selected. An uncertainty factor (UF) is applied 
to reflect uncertainties inherent in the extrapolation from laboratory 
animal data to humans and in the variations in sensitivity among 
members of the human population as well as other unknowns. An UF of 100 
is routinely used, 10X to account for interspecies differences and 10X 
for intraspecies differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose where the RfD is 
equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). 
Where an additional safety factor is retained due to concerns unique to 
the FQPA, this additional factor is applied to the RfD by dividing the 
RfD by such additional factor. The acute population Adjusted Dose 
(aPAD) is a modification of the RfD to accommodate this type of FQPA 
SF.
    For non-dietary risk assessments (other than cancer) the UF is used 
to

[[Page 9229]]

determine the level of concern (LOC). For example, when 100 is the 
appropriate UF (10X to account for interspecies differences and 10X for 
intraspecies differences) the LOC is 100. To estimate risk, a ratio of 
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is 
calculated and compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10\6\ or one in a million). Under 
certain specific circumstances, MOE calculations will be used for the 
carcinogenic risk assessment. In this non-linear approach, a ``point of 
departure'' is identified below which carcinogenic effects are not 
expected. The point of departure is typically a NOAEL based on an 
endpoint related to cancer effects though it may be a different value 
derived from the dose response curve. To estimate risk, a ratio of the 
point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for formetanate hydrochloride used for human risk assessment 
is shown in the following Table. In addition, as noted above in Unit 
IV., a detailed summary of the toxicological endpoints can be found in 
the Formetanate Hydrochloride IRED (which, as noted previously, is now 
proposed to become a final RED) (http://www.epa.gov/oppsrrd1/REDs/formetanatehcl_ired.pdf).

  Table 1.--Summary of Toxicological Endpoints and Doses for Formetanate Hydrochloride Dietary Risk Assessments
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                                                                   Hazard Based FQPA        Endpoint for Risk
          Exposure Scenario                  Dose UF/MOE             Safety Factor              Assessment
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Acute Dietary females 13-50 years of     Not applicable; the endpoint selected for the general population (see
 age                                     below) based on, and therefore protective of, this population subgroup.
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Acute Dietary general population       BMDL110 = 0.065 mg/kg    1X                       BMDL10 for female pup
                                       UF = 100 (a)...........  Acute PAD = 0.00065 mg/   brain AChE in the
                                       aRfD = 0.00065 mg/kg...   kg..                     Comparative ChE study.
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Chronic Dietary                           Not applicable; data on formetanate hydrochloride indicate that the
                                          magnitude of cholinesterase inhibition (ChEI) does not increase with
                                             continued exposure because of the rapid reversibility of ChEI.
                                             Therefore, chronic exposure to formetanate hydrochloride may be
                                                       considered as a series of acute exposures.
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Incidental Oral Short and               Not applicable. There are no current registrations for residential uses.
 intermediate terms
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Cancer                                            Group E Carcinogen; Classification: ``Not likely.''
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B. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.276) for the residues of formetanate 
hydrochloride, in or on a variety of raw agricultural commodities. Risk 
assessments were conducted by EPA to assess dietary exposures from 
formetanate hydrochloride in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a one day 
or single exposure. A tier 3, acute probabilistic dietary risk 
assessment was conducted using the Dietary Exposure Evaluation Model 
(DEEM-FCID, Version 2.03), which uses food consumption data from the 
USDA's Continuing Surveys of Food Intakes by Individuals (CSFII) from 
1994-1996 and 1998. Drinking water exposure was incorporated directly 
into the dietary exposure analysis. The dietary assessment relies on 
Pesticide Data Program (PDP) monitoring data from 2001 for oranges, 
grapefruit and pears. Anticipated residues for apples are derived using 
field trial data, since the PDP data reflect the late-season use on 
apples, which is no longer being supported by the registrant. Field 
trial residue data were submitted with the exemption request for both 
peeled and unpeeled onions. Since onions are generally peeled prior to 
eating, the peeled onion data were used in this assessment. No 
adjustment was made to account for the percent of onions treated (i.e., 
100% crop treated was assumed).
    ii. Chronic exposure. Cholinesterase inhibition (ChEI) is the only 
manifestation of exposure to formetanate HCl observed in the variety of 
toxicity studies conducted to support reregistration of this active 
ingredient. These formetanate HCl studies indicate that the magnitude 
of cholinesterase inhibition (ChEI) does not increase with continued 
exposure because of the rapid reversibility of ChEI. Therefore, chronic 
exposure to formetanate HCl may be considered as a series of acute 
exposures, indicating that a chronic dietary exposure assessment is not 
necessary.
    iii. Cancer. Formetanate hydrochloride is classified as a group 
``E'' carcinogen, and therefore a cancer exposure assessment is not 
required.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and 
information on the anticipated levels of pesticide residues in food and 
the actual levels of pesticide chemicals that have been measured in 
food. If EPA relies on such information, EPA must pursuant to FFDCA 
section 408(f)(1) require that data be provided 5 years after the 
tolerance is established, modified, or left in effect, demonstrating 
that the levels in food are not above the levels anticipated. Following 
the initial data submission, EPA is authorized to require similar data 
on a time frame it deems appropriate. For the present action, EPA will 
issue such data call-ins for information relating to anticipated 
residues as are required by FFDCA section 408(b)(2)(E) and authorized 
under FFDCA section 408(f)(1). Such data call-ins will be required to 
be submitted no later than 5 years from the date of issuance of this 
tolerance.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a

[[Page 9230]]

comprehensive dietary exposure analysis and risk assessment for 
formetanate hydrochloride in drinking water. Because the Agency does 
not have comprehensive monitoring data, drinking water concentration 
estimates are made by reliance on simulation or modeling taking into 
account data on the physical characteristics of formetanate 
hydrochloride. Further information regarding EPA drinking water models 
used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Tier II screening models, Pesticide Root Zone Model and Exposure 
Analysis Modeling System (PRZM and EXAMS) with the Index Reservoir and 
Percent Cropped Area adjustment (IR-PCA PRZM/EXAMS) were used to 
determine estimated surface water concentrations of formetanate HCL 
following application to apples in North Carolina, Pennsylvania and 
Oregon. As noted in previous sections of this document, additional 
detailed information regarding formetanate hydrochloride, including 
dietary exposure from drinking water can be found in the March 2006 
IRED (http://www.epa.gov/oppsrrd1/REDs/formetanatehcl_ired.pdf).
    Based on the PRZM/EXAMS model described above, the highest 
estimated environmental concentration (EEC) of formetanate 
hydrochloride for acute exposures is estimated to be 7.7 parts per 
billion (ppb) for surface water based on applications to apples in 
North Carolina.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model (DEEM-FCID\TM\, Version 2.03). 
For the acute dietary risk assessment, the entire distribution of 
estimated daily exposure values from the PRZM-EXAMS run was used 
probabilistically in the analysis to assess the contribution to 
drinking water.
    3. Non-dietary exposure. The term ``residential exposure'' is used 
in this document to refer to non-occupational, non-dietary exposure 
(e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Formetanate hydrochloride is not registered for use on any sites 
that would result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Formetanate hydrochloride belongs to the N-methyl carbamate class 
of chemicals for which a revised cumulative assessment has recently (72 
FR 54656, September 26, 2007) been published by the Agency in the 
Federal Register for comment (http://www.epa.gov/oppsrrd1/REDs/nmc_revised_cra.pdf). This ``Revised N-Methyl Carbamate Cumulative Risk 
Assessment'' concludes that the cumulative risks from food, water, and 
residential exposure to N-methyl carbamates do not exceed the Agency's 
level of concern.
    Field trial data for formetanate hydrochloride residues on peeled 
onion (the value used in dietary risk assessment) are below the LOD of 
0.0007 ppm. Field trial data are much more conservative (often 1 to 2 
orders of magnitude higher in residue) than the PDP data generally used 
for registered uses in the cumulative assessment. Using residue values 
at half the LOQ of 0.002 ppm had negligible impact on dietary risk for 
formetanate hydrochloride in the N-methyl carbamate cumulative 
assessment. Furthermore, food derived from onion is not a significant 
contributor to the diet of infants less than 1 year old (the most 
sensitive subpopulation in the N-methyl carbamate cumulative 
assessment).
    If a tolerance were currently in place for formetanate 
hydrochloride use on onion, it would be among the ``Insignificant 
Contributors'' that, in their entirety, account for only 3% of the 
total risk in the N-methyl carbamate ``risk cup.'' These 
``Insignificant Contributors'' had their tolerances fully reassessed on 
June 29, 2006 prior to completion of the full N-methyl carbamate 
cumulative assessment. See http://www.epa.gov/pesticides/cumulative/carbamates_commodity.pdf.
    In light of these residue findings for formetanate hydrochloride on 
onion, the Agency does not expect any significant contribution of 
exposure to the cumulative assessment and therefore, the conclusions 
from the revised cumulative risk assessment for the N-methyl carbamates 
remain unaffected by this emergency use on onions.

C. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the database on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. Formetanate HCl did not 
result in developmental toxicity in either rats or rabbits or in 
reproductive effects in the multi-generation reproduction study. There 
was no indication of increased offspring susceptibility in these 
studies.
    3. Conclusion. There is a complete toxicity database for 
formetanate hydrochloride and exposure data are complete or are 
estimated based on data that reasonably accounts for potential 
exposures. The Agency determined that the FQPA Safety Factor can be 
removed (reduced to 1X) due to lack of concern and no residual 
uncertainties for prenatal and/or postnatal toxicity. Due to the 
conservative, health-protective nature of the models and the input 
parameters, EPA believes exposure via drinking water will not be 
underestimated. Therefore, the current hazard and exposure data support 
reducing the FQPA Safety Factor to 1X. Additional information may be 
found in the March 2006 IRED (http://www.epa.gov/oppsrrd1/REDs/formetanatehcl_ired.pdf)

D. Aggregate Risks and Determination of Safety

    The Agency currently has two ways to estimate total aggregate 
exposure to a pesticide from food, drinking water, and residential 
uses. First, a screening assessment can be used, in which the Agency 
calculates drinking water levels of comparison (DWLOCs) which are used 
as a point of comparison against estimated drinking water 
concentrations (EDWCs). The DWLOC values are not regulatory standards 
for drinking water, but are theoretical upper limits on the 
concentration of a pesticide in drinking water that can be considered 
safe in light of total aggregate exposure to a pesticide in food and 
residential uses. More information on the use of DWLOCs in dietary 
aggregate risk assessments can be found at http://www.epa.gov/oppfead1/trac/science/screeningsop.pdf.
    More recently the Agency has used another approach to estimate 
aggregate exposure through food, residential and drinking water 
pathways. In this approach, modeled surface and ground water EDWCs are 
directly incorporated into the dietary exposure analysis, along with 
food. This provides a more realistic

[[Page 9231]]

estimate of exposure because actual body weights and water consumption 
from the CSFII are used. The combined food and water exposures are then 
added to estimated exposure from residential sources to calculate 
aggregate risks. The resulting exposure and risk estimates are still 
considered to be high end, due to the assumptions used in developing 
drinking water modeling inputs. The risk assessment for formetanate 
hydrochloride used in this tolerance document uses this approach of 
incorporating water exposure directly into the dietary exposure 
analysis.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to formetanate hydrochloride will occupy 36% of the aPAD for the U.S. 
population, 29% of the aPAD for females 13 years and older, 117% of the 
aPAD for all infants less than 1 year old and 69% of the aPAD for 
children 1 to 2 years old.
    These risk estimates are based on upper-end (99.9th percentile) 
exposure estimates for each population. The 99.9th percentile is used 
``in the first instance'' in estimating exposure for probabilistic 
acute dietary exposure assessments which are based on highly refined 
exposure inputs. EPA evaluates whether to vary from use of the 99.9th 
percentile in assessing exposure based on considerations primarily 
related to the conservativeness or lack thereof of the various inputs 
to the assessment, with particular emphasis on an examination of the 
conservativeness of those inputs that most greatly influence the risk 
estimate. There are several inputs to the current assessment that are 
quite conservative. First, anticipated residue data for apples is based 
on field trial data as opposed to PDP data; this is likely to 
substantially overstate residue levels in apples as consumed. Second, 
EPA assumed that 100% of the onion crop will be treated with 
formetanate. Actual percent crop treated is likely to be substantially 
lower than that, if for no other reason than use is only permitted in a 
few States. Third, and most important, the estimated residue levels in 
water are very conservative compared to the refined food estimates that 
generally cause EPA to rely on the 99.9th percentile. This is 
particularly critical because the estimated dietary exposure from 
drinking water is the principal driver of the risk assessment, 
accounting for 106% of the aPAD for infants when considered alone.
    The drinking water exposure estimates were based on PRZM-EXAMS 
surface water modeling results. The PRZM-EXAMS model is intended to 
provide upper-end estimates of pesticide residues in surface water. The 
models use an Index Reservoir based on an actual drinking water 
reservoir in Illinois (Shipman City Lake) that is known to be 
vulnerable to pesticide contamination. Pesticide loadings to the water 
body are modeled using local soils and weather data to reflect crop-
specific scenarios around the country. The conservativeness of this 
model and its tendency to overestimate residues was documented by EPA 
in an earlier tolerance proceeding. (69 FR 30042, 30060-30063, May 26, 
2004). Additionally, there are pesticide-specific factors here that 
insure that PRZM-EXAMS modeling results will overestimate residue 
levels in drinking water.
    The modeling results were adjusted by a Percent Cropped Area (PCA) 
factor of 0.87. In other words, the results assume that 87% of the 
watershed is cropped in apples (or other crops with similar use of 
formetanate) and that 100% of these crops are treated with formetanate 
HCl. The PCA factor does not consider the percent of the crop that is 
actually treated because detailed pesticide usage data (i.e., at the 
state or watershed level) are generally unavailable or inadequate. In 
the case of formetanate HCl, however, the national usage estimates 
suggest that a PCA factor of 0.87 significantly overestimates drinking 
water concentrations in many areas. Maximum percent crop treated (PCT) 
estimates for apple, pear, peach, orange and grapefruit are 5% or less, 
and maximum PCT estimates for lemon/lime and nectarine are 15% and 46%, 
respectively. Thus, while it is theoretically possible there could be 
water basins in the United States that are planted almost entirely with 
crops that may lawfully be treated with formetanate HCl and that all 
crops in that water basin would be treated with formetanate HCl, the 
probability of these two unlikely events occurring together is very 
low.
    Accordingly, it is EPA's judgment that use of the 99.9th percentile 
to estimate exposure significantly overstates exposure and thus the 
estimated slight exceedance of the aPAD (117%) for infants does not 
show a risk of concern. This is confirmed by the fact the estimated 
exposure for this population group declines below the aPAD at the 
99.86th percentile level.
    2. Chronic risk. As noted in Unit IV.B.1.ii. of this preamble, 
cholinesterase inhibition (ChEI) is the only manifestation of exposure 
to formetanate hydrochloride observed in the variety of toxicity 
studies conducted to support reregistration of this active ingredient. 
These formetanate hydrochloride studies indicate that the magnitude of 
cholinesterase inhibition (ChEI) does not increase with continued 
exposure because of the rapid reversibility of ChEI. Therefore, chronic 
exposure to formetanate hydrochloride may be considered as a series of 
acute exposures, indicating that a chronic dietary risk assessment is 
not necessary. Inasmuch as EPA has concluded that there is no acute 
risk of concern, chronic risk is also not of concern.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Formetanate hydrochloride is not registered for use on any sites 
that would result in residential exposure. Therefore, the aggregate 
risk is the sum of the chronic risk from food and water, which was 
previously addressed and is not of concern.
    4. Aggregate cancer risk for U.S. population. Formetanate 
hydrochloride is classified as a group ``E'' carcinogen and is 
therefore not expected to pose a cancer risk.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children, from aggregate 
exposure to formetanate hydrochloride residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    An adequate method is available for enforcement of the currently 
established plant tolerances Gas Chromatography with Electron Capture 
Detection (GC/ECD method (Method I); PAM Vol. II). For purposes of the 
Section 18 emergency exemption, EPA concludes that this method is 
sufficient to enforce the recommended onion tolerance.

B. International Residue Limits

    There are no CODEX residue limits for residues of formetanate 
hydrochloride on onions, therefore, harmonization is not an issue.

VI. Conclusion

    Therefore, a time-limited tolerance is established for residues of 
formetanate hydrochloride; m-[[(dimethylamino)methylene]amino]phenyl 
methylcarbamate hydrochloride in or on onion, dry bulb at 0.02 ppm. 
This time-limited tolerance expires and is revoked on December 31, 
2008.

[[Page 9232]]

VII. Statutory and Executive Order Reviews

    This final rule establishes a time-limited tolerance under section 
408 of FFDCA. The Office of Management and Budget (OMB) has exempted 
these types of actions from review under Executive Order 12866, 
entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). 
Because this rule has been exempted from review under Executive Order 
12866, this rule is not subject to Executive Order 13211, Actions 
Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 
13045, entitled Protection of Children from Environmental Health Risks 
and Safety Risks (62 FR 19885, April 23, 1997). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it 
require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a FIFRA section 18 exemption under section 408 of FFDCA, such as the 
tolerance in this final rule, do not require the issuance of a proposed 
rule, the requirements of the Regulatory Flexibility Act (RFA) (5 
U.S.C. 601 et seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 6, 2000) do not apply to this rule. In addition, This 
rule does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: February 6, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.276 is amended by adding text to paragraph (b) to reads 
as follows:


Sec.  180.276  Formetanate hydrochloride; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. A time-limited tolerance is 
established for residues of the insecticide formetanate hydrochloride 
(m-[[(dimethylamino) methylene]amino]phenyl methylcarbamate 
hydrochloride) in connection with use of the pesticide under section 18 
emergency exemptions granted by EPA. The tolerances in this paragraph 
will expire and are revoked on the date specified in the following 
table.

------------------------------------------------------------------------
                                            Parts per     Expiration/
                 Commodity                   million    revocation date
------------------------------------------------------------------------
Onion, dry bulb                                  0.02           12/31/08
------------------------------------------------------------------------

* * * * *
[FR Doc. E8-2906 Filed 2-19-08; 8:45 am]
BILLING CODE 6560-50-P